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Cidara Therapeutics Doses First Subjects in Phase 2b Trial of CD388 for Influenza Prevention

• Cidara Therapeutics has initiated the Phase 2b NAVIGATE trial to assess CD388 for pre-exposure prophylaxis against seasonal influenza. • The trial will enroll 5,000 healthy, unvaccinated adults across sites in the US and UK, evaluating different doses of CD388 versus placebo. • CD388, a drug-Fc conjugate, aims to provide universal protection against influenza A and B strains, regardless of immune status, with a single dose. • The primary endpoint is to compare rates of laboratory-confirmed influenza between CD388 and placebo groups during the influenza season.

Cidara Therapeutics, Inc. (Nasdaq: CDTX) has announced the dosing of the first subjects in its Phase 2b NAVIGATE trial, designed to evaluate the efficacy and safety of CD388 for the pre-exposure prevention of seasonal influenza. The randomized, double-blind, controlled trial will enroll 5,000 healthy, unvaccinated adult participants across clinical sites in the United States and the United Kingdom.

Trial Design and Objectives

The NAVIGATE trial will administer three different doses of CD388 or a placebo as a single dose at the beginning of the influenza season. Participants will be monitored throughout the season to detect breakthrough cases of influenza. The primary objective is to compare the rates of laboratory-confirmed and clinically confirmed influenza among subjects receiving CD388 versus those receiving the placebo.

CD388: A Novel Approach to Influenza Prevention

CD388 is an investigational drug-Fc conjugate (DFC) composed of multiple copies of a potent small molecule neuraminidase inhibitor, stably conjugated to a proprietary Fc fragment of a human antibody. Unlike vaccines or monoclonal antibodies, DFCs are low molecular weight biologics designed to function as long-acting small molecule inhibitors. This design aims to provide broad protection against all known strains of seasonal and pandemic influenza with a single subcutaneous or intramuscular administration.
Jeffrey Stein, Ph.D., president and chief executive officer of Cidara Therapeutics, stated, "Effective new options are needed to prevent influenza, particularly for people who do not respond well to seasonal flu vaccines. Since CD388 is not a vaccine, its activity does not rely upon an immune response and is thereby expected to work regardless of immune status. In addition, CD388 has demonstrated the potential to prevent infection by both seasonal and pandemic strains of influenza A and B."

Significance of CD388

The development of CD388 addresses a critical unmet need in influenza prevention, particularly for individuals with compromised immune systems or those who do not respond adequately to traditional vaccines. Its unique mechanism of action, independent of an immune response, offers a potential advantage over existing preventive measures. The FDA granted Fast Track Designation to CD388 in June 2023, underscoring its potential to address a significant public health concern.
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Reference News

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Cidara Therapeutics Announces First Subjects Dosed in Phase 2b NAVIGATE Trial ...
biospace.com · Sep 23, 2024

Cidara Therapeutics initiates Phase 2b NAVIGATE trial to evaluate CD388 for influenza pre-exposure prophylaxis, enrollin...

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